Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1 for Influenza, Human

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
AMR Lexington, Lexington, KY
Influenza, Human
Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying different ways to give the flu vaccine to people. They want to see if it is better to give it one way or another. They will follow up with the people who got the vaccine to see how well it worked. The experimental treatment in this trial is aIIV-B, which will be given as a single dose intramuscularly on Day 1. This treatment is for Influenza, Human and involves immunotherapy. aIIV-B has been previously approved by the FDA for a different condition, so all patients in this trial will receive the experimental treatment and there will be no placebo group.

Treatment Effectiveness

Study Objectives

4 Primary · 1 Secondary · Reporting Duration: 180 days post-vaccination

180 days post-vaccination
The Percentage of Subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
28 days post-vaccination
Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains
Immunogenicity Endpoint: Microneutralization (MN) titers against vaccine A and B influenza strains
The Percentage of Subjects with Unsolicited Adverse Events
7 days post-vaccination
The Percentage of Subjects with Solicited Local and Systemic Reactions

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Licensed IIV
1 of 4
aIIV-B Investigational
1 of 4
IIV-A Investigational
1 of 4
aIIV-C Investigational
1 of 4
Active Control
Experimental Treatment

1000 Total Participants · 4 Treatment Groups

Primary Treatment: Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1 · No Placebo Group · Phase 2

aIIV-B Investigational
Biological
Experimental Group · 1 Intervention: Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1 · Intervention Types: Biological
IIV-A Investigational
Biological
Experimental Group · 1 Intervention: Experimental: IIV-A Investigational IIV-A will be administered as a single dose intramuscularly on Day 1 · Intervention Types: Biological
aIIV-C Investigational
Biological
Experimental Group · 1 Intervention: Experimental: aIIV-C Investigational aIIV-C will be administered as a single dose intramuscularly on Day 1 · Intervention Types: Biological
Licensed IIV
Biological
ActiveComparator Group · 1 Intervention: Active Comparator: Licensed IIV IIV will be administered as a single dose intramuscularly on Day 1 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 180 days post-vaccination
Closest Location: AMR Lexington · Lexington, KY
Photo of Lexington 1Photo of Lexington 2Photo of Lexington 3
2020First Recorded Clinical Trial
2 TrialsResearching Influenza, Human
5 CompletedClinical Trials

Who is running the clinical trial?

SeqirusLead Sponsor
51 Previous Clinical Trials
72,105 Total Patients Enrolled
46 Trials studying Influenza, Human
70,827 Patients Enrolled for Influenza, Human

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects must be 18 years of age or older.
You are 50 years of age or older.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.